A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers
A Randomised, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-4129 in Healthy Subjects; Including the Effect of Gender and Age on the Pharmacokinetics of a Single Dose of MT-4129 in Healthy Subjects
1 other identifier
interventional
116
1 country
1
Brief Summary
The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2016
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 18, 2017
May 1, 2017
6 months
October 31, 2016
May 16, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
Safety and Tolerability as measured by incidence and severity of adverse events
Up to Day 14
Safety and Tolerability as measured by vital signs
Up to Day 14
Safety and Tolerability as measured by ECG
Up to Day 14
Safety and Tolerability as measured by clinical laboratory assessments
Up to Day 14
Safety and Tolerability as measured by Hormone assessments
Up to Day 10
Safety and Tolerability as measured by physical examination
Up to Day 14
Secondary Outcomes (24)
Maximum observed plasma concentration (Cmax) of MT-4129
Up to Day 10
Measured time of maximum observed plasma concentration (tmax) of MT-4129
Up to Day 10
Apparent terminal elimination half-life (t1/2) of MT-4129
Up to Day 10
AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129
Up to Day 8
AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129
Up to Day 9
- +19 more secondary outcomes
Study Arms (2)
Single ascending dose, MT-4129 or Placebo
EXPERIMENTALMultiple ascending dose, MT-4129 or Placebo
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy and free from clinically significant illness or disease
- Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
- A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2
You may not qualify if:
- Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, neurological, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
- Clinically relevant abnormal medical history, physical findings or laboratory values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pharmaceutical Research Associates (PRA) Health Sciences
City Name, Netherlands
Study Officials
- STUDY DIRECTOR
General Manager
Tanabe Pharma Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2016
First Posted
November 2, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 18, 2017
Record last verified: 2017-05